Novo Nordisk (NYSE:) disclosed today that the US Food and Drug Administration (FDA) has sanctioned an expanded use for its drug Wegovy®. This approval allows the medication to be marketed for reducing the likelihood of major adverse cardiovascular events (MACE), which include cardiovascular death, non-fatal heart attacks, or non-fatal strokes. This indication is specifically for adults who are overweight or obese and have pre-existing cardiovascular disease (CVD).
The FDA’s decision is rooted in the results of the SELECT cardiovascular outcomes trial. Data from this study revealed that Wegovy® could significantly decrease the risk of MACE by 20% compared to a placebo, in conjunction with standard care. The trial also highlighted that the benefits of Wegovy® were consistent across various subgroups, including different ages, genders, races, ethnicities, body mass indices (BMIs), and levels of renal function impairment.
Furthermore, the updated drug label now includes SELECT trial data indicating a 15% reduction in cardiovascular death and a 19% reduction in death from any cause, both in comparison to placebo. These figures underscore the potential impact of the drug on patient longevity.
Martin Holst Lange, executive vice president and head of Development at Novo Nordisk, expressed the company’s satisfaction with the FDA’s approval, emphasizing the significance of Wegovy® as the first therapy of its kind to help individuals manage weight and mitigate cardiovascular risks. The company anticipates that this approval will be a crucial development for patients living with obesity and cardiovascular disease.
In addition to the FDA approval, Novo Nordisk has submitted a request for label expansion in the European Union, with an expected decision in 2024. This news is based on a press release statement and reflects the company’s ongoing commitment to addressing significant health challenges associated with obesity and cardiovascular disease.
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